| Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
|---|
| 510(K) Number |
K121636 |
|---|
| Models |
86-0007-1-XXXX,
86-0009-0-XXXX,
86-100X-0-XXXX,
86-1610-2-XXXX
|
| Device Name |
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT |
|---|
| Applicant |
| TGM MEDICAL, INC. |
| 5145 golden foothill parkway |
| suite 175 |
|
el dorado hills,
CA
95762
|
|
| Contact |
prakash pai |
| Regulation Number | 888.3358
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 06/04/2012 |
|---|
| Decision Date | 10/24/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
